Pathology testing and clinical laboratory testing are important aspects of modern diagnostic and prognostic practices. Control samples are often used to maintain quality control (QC) for reproducibility of test results by immunohistochemical (IHC) staining, in situ hybridization (ISH), and other methods of molecular analyses.
Some of the controls available for IHC staining and ISH staining of tumor tissues and other diseased tissues are cancer tissue-derived controls. However such types of controls are only available in very limited quantities, and once such controls are exhausted, replacement controls with the same characteristics may be unavailable. Other types of available controls are cancer cell lines-derived controls. However, such types of controls do not exhibit consistent patterns and levels of cellular expression of a given marker, or heterogeneity of said expression, which is ubiquitous to tumor tissues. As such, these controls have little or no morphological resemblance to actual tumor tissues.